Heart Failure Clinical Trial
— RAPID-HELPA randomized pilot study of spinal cord stimulation in patients with chronic heart failure aiming to show whether this therapy impacts central haemodynamic and autonomic regulations.
Status | Terminated |
Enrollment | 3 |
Est. completion date | September 2017 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Patients with chronic heart failure II-III class (NYHA); 2. Age 18-70 years; 3. Left ventricle ejection fraction =35%; 4. Optimal heart failure management according to the guidelines; 5. Signed informed consent Exclusion Criteria: 1. Heart transplant list; 2. Acute conditions, including systemic infection; 3. Reversible cause of heart failure (thyroid gland diseases, alcoholic intoxication etc); 4. Planned elective heart surgery or intervention; 5. Recent (3 months) myocardial infarction, coronary intervention; 6. Heart failure decompensation; 7. Implanted cardiac resynchronization device < 6 months ago; 8. Contraindications for lumbal puncture or placement of a spinal cord pacing electrode; 9. Permanent atrial fibrillation; 10. Stroke or TIA < 6 months ago; 11. Pulmonary thromboembolist < 3 months ago; 12. Hypertrophic cardiomyopathy with obstruction; 13. Angina III-IV class, or congestive heart failure IV class; 14. Participation in any other clinical trial; 15. Women of childbearing possibility without appropriate contraception, pregnant, or breastfeeding women. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Federal North-West Medical Research Centre | Saint-Petersburg |
Lead Sponsor | Collaborator |
---|---|
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dynamics of NT-pro-BNP-level | NT-pro-BNP-level baseline, 30 days and 60 days (intervention) NT-pro-BNP-level baseline, 30 days (control) | Baseline, 30, 60 days | |
Secondary | Exercise capacity as determined by a cardiopulmonary test | Exercise capacity (cardiopulmonary test) baseline, 30 days and 60 days (intervention) Exercise capacity (cardiopulmonary test) baseline, 30 days (control) | Baseline, 30, 60 days | |
Secondary | Changes in heart failure functional class | Baseline, 30, 60 days | ||
Secondary | Changes in atrial effective refractory period | Baseline, 30, 60 days | ||
Secondary | Number of participants with ventricular arrhythmias | Baseline, 30, 60 days | ||
Secondary | Autonomic regulation tests results change | Tilt-test, Valsalva maneuver, deep breath test | Baseline, 30, 60 days | |
Secondary | Levels of pro-inflammatory plasma markers | TNF-a, CRP, fibrinogen | Baseline, 30, 60 days | |
Secondary | Changes in left ventricle ejection fraction as determined by echocardiography | Baseline, 30, 60 days | ||
Secondary | Left ventricle volume | Baseline, 30, 60 days | ||
Secondary | Number of participants with complications | Baseline, 30, 60 days |
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